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Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section

Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section. Randomized, Single Blind, Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05404490
Enrollment
202
Registered
2022-06-03
Start date
2022-06-01
Completion date
2022-11-30
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Cesarean section, Postoperative Pain, Bupivacain

Brief summary

This study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (VAS) and assessing the need for rescue analgesia after surgery.

Interventions

DRUGBupivacain

20 mL of bupivacaine 0.5% will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.

DRUGPlacebo

20 mL of Normal Saline Solution will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.

Sponsors

Saint Thomas Hospital, Panama
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Single-Blind

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Gestational age ≥ 36 weeks * Elective cesarean section * Transverse segmental caesarean section Pfannenstiel type * Spinal anesthesia * Maternal age 18 to 45 years * Any gravaparity * Patient ASA I or II

Exclusion criteria

* Any patient who does not meet the inclusion criteria. * Emergency cesarean section * History of chronic or neuropathic pain * Patient with cardiopulmonary disease * Known allergies to the drugs used in the study * Patient who does not wish to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain72 hoursLevel of pain described using a Visual Analogue Scale (VAS) Lower value: 0 (no pain) Higher value: 10 (worst pain possible)

Secondary

MeasureTime frameDescription
Need for rescue medication72 hoursNumber of participants that required an additional analgesic for pain control

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026